Effectiveness of a Diabetes Self-Management Program Among Ethnic Minority Elderly in Rural Thailand (DSM-EME)

The Effectiveness of Diabetes Self-Management Intervention on Glycemic Control, Self-management and Psychological Distress for Ethnic Minority Elderly in Rural Areas in Thailand: A Randomized Controlled Trial

Type 2 diabetes is a serious health condition that affects many older adults from ethnic minority communities in Northern Thailand. These populations, often referred to as hill tribes, include groups such as Akha, Lahu, Hmong, and Lisu who live in remote mountainous areas of Chiang Rai Province. Previous research has found that the prevalence of type 2 diabetes among ethnic minority elderly in Thailand is 16.8%, which is higher than the general Thai population. Many of these individuals have difficulty managing their diabetes because of low literacy, limited access to healthcare, language barriers, and poverty.

The purpose of this study was to test whether a structured Diabetes Self-Management (DSM) program could help ethnic minority older adults (aged 60 years or older) improve their blood sugar control, increase their ability to manage diabetes on their own, and reduce emotional distress related to diabetes.

This study used a cluster randomized controlled trial design. Villages in Chiang Rai Province were randomly assigned to either the DSM intervention group or the usual care group. A total of 108 participants (54 per group) were enrolled. Participants in the intervention group attended a 6-week education program with weekly interactive sessions covering diabetes knowledge, healthy eating, physical activity, medication management, problem solving, risk reduction, and emotional coping. Two home visits were also provided at Weeks 8 and 10. Participants in the usual care group received standard brief discharge education and routine follow-up visits.

The main outcome measured was the change in HbA1c (a blood test that shows average blood sugar levels over the past 2 to 3 months) from the start of the study to 12 weeks later. Additional outcomes included changes in diabetes self-management behaviors and diabetes-related psychological distress, measured using validated questionnaires.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Psychological Distress; Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Behavioral: Diabetes Self-Management Education (DSME) Program; Other: Usual Care

Detailed Description

This study employed a cluster randomized controlled trial (cRCT) design to evaluate the effectiveness of a culturally tailored Diabetes Self-Management (DSM) intervention among ethnic minority elderly (EME) aged 60 years or older with type 2 diabetes mellitus (T2DM) in rural Chiang Rai Province, Northern Thailand.

BACKGROUND AND RATIONALE:

Ethnic minority populations in Northern Thailand, commonly referred to as hill tribes, experience disproportionately high rates of T2DM compared to the general Thai population. These communities face multiple barriers to effective diabetes management, including geographic isolation, low health literacy, limited Thai language proficiency, cultural differences in health beliefs, and restricted access to healthcare services. Despite the well-established evidence supporting diabetes self-management education for improving glycemic outcomes, few interventions have been designed specifically for low-literacy, culturally diverse elderly populations in low-resource rural settings.

THEORETICAL FRAMEWORK:

The DSM intervention was developed based on the Chronic Care Model (CCM), which emphasizes patient-centered care through self-management support, community resource linkage, health system integration, clinical information systems, and decision support. The intervention content was informed by the seven core self-management skills defined by the American Association of Diabetes Educators (AADE7): healthy eating, being active, monitoring, taking medications, problem solving, reducing risks, and healthy coping.

RANDOMIZATION AND ALLOCATION:

Eighteen villages with ethnic minority populations were identified and stratified into two groups of nine villages each based on geographical region, proportion of ethnic minority residents, and expected T2DM caseloads. Villages were randomly allocated in a 1:1 ratio to either the DSM intervention arm or the usual care control arm. The randomization sequence was generated by an independent statistician using a computer-based random number generator. Allocation concealment was maintained through sealed opaque envelopes opened only after each village confirmed participation. Recruitment within villages was completed prior to revealing allocation to recruiters to minimize recruitment bias.

INTERVENTION ARM:

Participants in the intervention arm received a 6-week structured DSM program consisting of one interactive session per week, each lasting 1 to 3 hours. Sessions were delivered by a multidisciplinary team including endocrinologists, nurse practitioners, dieticians, and village health volunteers (VHVs). Teaching methods were specifically adapted for low-literacy populations and incorporated visual flipcharts, picture-based symptom diaries with color codes and symbols, hands-on food demonstrations using locally available ingredients, glucometer training, role-play scenarios, and group discussions conducted with native-language translation support from VHVs.

Week 1 focused on diabetes fundamentals and symptom management, including recognition of hypoglycemia, hyperglycemia, and emotional distress. Week 2 addressed culturally appropriate healthy eating using the plate model and hand method for portion control. Week 3 introduced safe physical activities adapted for elderly bodies, including walking, stretching, and light gardening. Week 4 covered medication adherence and blood glucose self-monitoring with hands-on glucometer practice. Week 5 addressed problem solving and risk reduction through case-scenario role-plays for hypoglycemia management and daily foot care. Week 6 focused on healthy coping strategies, stress management, and effective use of local healthcare services.

Following the 6-week workshop phase, two home visits were conducted at Weeks 8 and 10 by nurses and VHVs to reinforce skills, review symptom and diet records, check medication adherence, and provide emotional support.

CONTROL ARM:

Participants in the control arm received standard usual care consisting of a one-time 10 to 15 minute face-to-face discharge education session delivered by a nurse practitioner not involved in the study intervention. Content included general information about T2DM, dietary advice, exercise recommendations, risk factor awareness, and self-monitoring instructions. No teach-back method, interactive activities, or structured follow-up education was provided. Participants attended scheduled outpatient follow-up visits as per the routine hospital system.

CONTAMINATION PREVENTION:

Separate teams delivered the intervention and control activities, and sessions were scheduled independently across clusters to minimize the risk of contamination between groups.

BLINDING:

Participants and intervention providers could not be blinded due to the nature of the behavioral intervention. Outcome assessors who collected HbA1c measurements and administered questionnaires were blinded to group allocation and were not involved in intervention delivery.

OUTCOME ASSESSMENT:

All outcomes were assessed at baseline (Week 0) and at 12 weeks after the start of the intervention. The primary outcome was change in glycated hemoglobin (HbA1c), measured via blood test at sub-district health promoting hospitals. Secondary outcomes included change in diabetes self-management behaviors measured by the Diabetes Self-Management Questionnaire (DSMQ, Thai version, 30 items across five domains, scored 30 to 150), and change in diabetes-related psychological distress measured by the 17-item Diabetes Distress Scale (DDS-17, four dimensions, 6-point Likert scale).

SAMPLE SIZE:

The sample size was calculated based on an effect size of 0.77 from a previous related study, with a significance level of 0.05 and statistical power of 0.90, yielding 45 participants per group. After accounting for an anticipated 20% attrition rate, 54 participants per group (108 total) were required.

STATISTICAL ANALYSIS:

Baseline demographic characteristics were described using means and standard deviations for continuous variables and frequencies and percentages for categorical variables. Paired t-tests and independent t-tests were used to compare within-group and between-group differences in study outcomes.

ETHICAL CONSIDERATIONS:

The study was approved by the Chiang Rai Province Public Health Research Ethics Committee (Approval No. CRPPHO 059/2568) and the Taipei Medical University-Joint Institutional Review Board (Approval No. N202511006). All procedures adhered to the principles of the Declaration of Helsinki. Gatekeeper consent was obtained from village leaders and local health staff prior to enrollment. Written informed consent or a thumbprint with a witness signature was obtained from each participant.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Changwat Chiang Rai
    • Chiang Rai, Changwat Chiang Rai, Thailand, 57100
      • Sub-district Health Promoting Hospitals (SDHPHs), Chiang Rai Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ethnic minority elderly aged 60 years or older residing in rural mountainous villages in Chiang Rai Province, Northern Thailand (including Akha, Lahu, Hmong, and Lisu communities)
• Diagnosed with type 2 diabetes mellitus (T2DM) for at least one year
• HbA1c level greater than 6.5%
• Mini-Mental State Examination (MMSE) score of 24 or higher
• Ability to communicate in Thai language
• Willing and able to provide written informed consent or thumbprint with witness signature

Exclusion Criteria:

• Unable to complete the informed consent process
• Mini-Mental State Examination (MMSE) score below 24, indicating possible cognitive impairment
• Severe or unstable medical conditions that would preclude participation in a 6-week group education program (e.g., acute hospitalization, severe mobility limitations requiring full-time assistance)
• Currently participating in another diabetes education or self-management intervention study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetes Self-Management Intervention Group; Participants in villages allocated to the intervention arm received a 6-week structured Diabetes Self-Management Education (DSME) program consisting of weekly interactive sessions (1 to 3 hours each) delivered by a multidisciplinary team including endocrinologists, nurse practitioners, dieticians, and village health volunteers. Content covered seven core self-management skills: symptom management, healthy eating, physical activity, medication adherence and glucose monitoring, problem solving, risk reduction, and healthy coping. Teaching methods were adapted for low-literacy populations using visual flipcharts, picture-based diaries, food demonstrations, hands-on glucometer training, role-play scenarios, and native-language translation support. Two follow-up home visits were conducted at Weeks 8 and 10 for skills reinforcement and emotional support.	Behavioral: Diabetes Self-Management Education (DSME) Program; A culturally tailored 6-week diabetes self-management education program grounded in the Chronic Care Model and the seven core self-management skills defined by the American Association of Diabetes Educators. The program consisted of six weekly interactive group sessions: Week 1 covered diabetes fundamentals and symptom management; Week 2 addressed culturally appropriate healthy eating using the plate model and hand method for portion control; Week 3 introduced safe physical activities adapted for elderly participants; Week 4 focused on medication adherence and blood glucose self-monitoring with hands-on glucometer practice; Week 5 addressed problem solving and risk reduction through role-play scenarios for hypoglycemia management and daily foot care; Week 6 covered healthy coping strategies, stress management, and effective use of local healthcare services. Sessions were delivered by endocrinologists, nurse practitioners, dieticians, and village health volunteers who provided native-la
Active Comparator: Usual Care Control Group; Participants in villages allocated to the control arm received standard usual care provided by local health services. This consisted of a one-time 10 to 15 minute face-to-face discharge education session delivered by a nurse practitioner not involved in the study intervention. Content included general information about type 2 diabetes, dietary advice, exercise recommendations, risk factor awareness, and self-monitoring instructions. No teach-back method, interactive activities, structured follow-up education, or home visits were provided. Participants attended scheduled outpatient follow-up visits as per the routine hospital system.	Other: Usual Care; Standard guideline-based discharge education for type 2 diabetes consisting of a one-time 10 to 15 minute face-to-face verbal education session delivered by a nurse practitioner not involved in the study intervention. Content included basic knowledge of type 2 diabetes, general dietary advice, exercise recommendations, risk factor awareness, complication prevention guidance, and self-monitoring instructions. A hospital-provided leaflet was given if available. No interactive activities, teach-back method, structured follow-up education, or home visits were included. Participants attended routine outpatient follow-up visits as scheduled by the hospital system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated Hemoglobin (HbA1c)	Change in HbA1c level (%) from baseline to 12 weeks. HbA1c was measured via venous blood sample collected at sub-district health promoting hospitals (SDHPHs) by nurse practitioners. HbA1c reflects average blood glucose control over the preceding 2 to 3 months. A decrease in HbA1c indicates improved glycemic control.	Baseline (Week 0) and 12 weeks after the start of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetes Self-Management Behaviors (DSMQ)	Change in total score on the Diabetes Self-Management Questionnaire (DSMQ), Thai version, from baseline to 12 weeks. The DSMQ consists of 30 items across five domains: general health, diet, exercise, medication, and eye care. Each item is rated on a 5-point scale (1=never do to 5=always). Total scores range from 30 to 150. Higher scores indicate better self-management behaviors.	Baseline (Week 0) and 12 weeks after the start of the intervention
Change in Diabetes-Related Psychological Distress (DDS-17)	Change in mean score on the 17-item Diabetes Distress Scale (DDS-17) from baseline to 12 weeks. The DDS-17 measures distress across four dimensions: emotional burden (5 items), physician-related distress (4 items), regimen-related distress (5 items), and interpersonal distress (3 items). Items are rated on a 6-point Likert scale (1=no problem to 6=serious problem). Higher scores indicate greater psychological distress.	Baseline (Week 0) and 12 weeks after the start of the intervention

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Chiang Rai Public Health Office; Mae Fah Luang University

Publications and helpful links

General Publications

• Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
• Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001 Nov-Dec;20(6):64-78. doi: 10.1377/hlthaff.20.6.64.
• Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
• Thanakwang K, Thinganjana W, Konggumnerd R. Psychometric properties of the Thai version of the Diabetes Distress Scale in diabetic seniors. Clin Interv Aging. 2014 Aug 16;9:1353-61. doi: 10.2147/CIA.S67200. eCollection 2014.
• Powers MA, Bardsley JK, Cypress M, Funnell MM, Harms D, Hess-Fischl A, Hooks B, Isaacs D, Mandel ED, Maryniuk MD, Norton A, Rinker J, Siminerio LM, Uelmen S. Diabetes Self-management Education and Support in Adults With Type 2 Diabetes: A Consensus Report of the American Diabetes Association, the Association of Diabetes Care & Education Specialists, the Academy of Nutrition and Dietetics, the American Academy of Family Physicians, the American Academy of PAs, the American Association of Nurse Practitioners, and the American Pharmacists Association. Diabetes Care. 2020 Jul;43(7):1636-1649. doi: 10.2337/dci20-0023. Epub 2020 Jun 8. No abstract available.
• Apidechkul T. Prevalence and factors associated with type 2 diabetes mellitus and hypertension among the hill tribe elderly populations in northern Thailand. BMC Public Health. 2018 Jun 5;18(1):694. doi: 10.1186/s12889-018-5607-2.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Actual): February 19, 2026
• Study Completion (Actual): February 19, 2026

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: HbA1c; Self-Management Education; Glycemic Control; Diabetes Distress; Diabetes Self-Management; Ethnic Minority Elderly; Hill Tribe
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Hyperglycemia
• Other Study ID Numbers: TMU-JIRB: N202511006; CRPPHO 059/2568 (Other Identifier: Chiang Rai Province Public Health Research Ethics Committee (CRPPHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated during the current study are not publicly available due to the small sample size and the potential risk of re-identification of participants from a vulnerable ethnic minority population in a geographically identifiable rural area. De-identified data may be available from the corresponding author upon reasonable request and subject to ethical approval from the Chiang Rai Province Public Health Research Ethics Committee (CRPPHO) and the Taipei Medical University-Joint Institutional Review Board (TMU-JIRB).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No